| CTRI Number |
CTRI/2025/12/099170 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological Medical Device Surgical/Anesthesia Preventive Screening Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing intramarrow penetration with and without hyaluronic acid gel after gum surgery in patients with bone loss |
|
Scientific Title of Study
|
Comparative evaluation of open flap debridement with intramarrow penetration with and without Hyaluronic acid gel in the treatment of horizontal bone defect - clinico radiographic study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praise Jose |
| Designation |
Post Graduate Student |
| Affiliation |
Periodontics |
| Address |
Department no. 4 , Periodontics and implantology
Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Department no. 4,Periodontics and implantology
Coorg Institute of Dental Sciences
Maggula road
Virajpet Kodagu 571218 Kodagu KARNATAKA 571218 India |
| Phone |
07907195185 |
| Fax |
|
| Email |
praisjose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Praise Jose |
| Designation |
Post Graduate Student |
| Affiliation |
Periodontics |
| Address |
Department no. 4,Periodontics and implantology
Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Department no. 4,Periodontics and implantology
Coorg Institute of Dental Sciences
Maggula road
Virajpet Kodagu 571218 Kodagu KARNATAKA 571218 India |
| Phone |
07907195185 |
| Fax |
|
| Email |
praisjose@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr RADHIKA B |
| Designation |
PROFESSOR |
| Affiliation |
Periodontics |
| Address |
Department no. 4,Periodontics and implantology,
Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Department no. 4,Periodontics and Implantology,
Coorg Institute of Dental Sciences
Maggula road
Virajpet Kodagu 571218 Kodagu KARNATAKA 571218 India |
| Phone |
9742096982 |
| Fax |
|
| Email |
radika_b24@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 |
|
|
Primary Sponsor
|
| Name |
Dr Praise Jose |
| Address |
Department no.4
Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praise Jose |
Coorg institute of dental sciences |
Department no. 4,Periodontics and implantology,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Kodagu KARNATAKA |
07907195185
praisjose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intramarrow penetration |
open flap debridement with intramarrow penetration is done on 3mm below bone crest |
| Comparator Agent |
intramarrow penetration and hyaluronic acid gel |
open flap debridement with intramarrow penetration and hyaluronic acid gel is done 3mm below bone crest. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patient diagnosed with Stage II periodontitis, as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions. |
|
| ExclusionCriteria |
| Details |
Ptients who has systemic diseases, pregnancy and habit of smoking are excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone fill in the horizontal bone loss area with intramarrow penetration and open flap debridement. |
Bone fill in the horizontal bone loss area with intramarrow penetration and open flap debridement.At baseline and 3 month cbct is taken to evaluate bone fill. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bone fill in horizontal bone loss area with intramarrow penetration, hyaluronic acid gel and open flap debridement. |
Bone fill in horizontal bone loss area with intramarrow penetration, hyaluronic acid gel and open flap debridement. Bone level is evaluated at baseline and 3 month with cbct. |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis causes inflammation and destruction of
the supporting alveolar bone and periodontal ligament. The periodontal disease
alters the morphologic features of bone in addition to reducing height. It
leads to various patterns of bone loss, of which horizontal and vertical bone
loss are the most common bone destruction patterns. Performing
Intramarrrow penetration (IMP) in the surgical site creates a close spatial
correlation between angiogenesis and bone formation. The vessel-rich medullary
opening space would facilitate capillary sprouting and enhance vascular access
into the surgical site. A local increase in bone morphogenetic proteins
and other growth factors from the injured cortical surface, endosteal area, and
wounded vessel area can enhance further new bone formation. Open flap debridement (OFD) is used in
various periodontal flap techniques with intrasulcular incisions and is used to
treat bony defects. Hyaluronic
acid (HA), a naturally occurring polysaccharide, is regarded as an essential
component of the extracellular matrix in connective tissues of the human body.
HA has been extensively used in dentistry, especially in periodontology, due to
its bacteriostatic, fungistatic, anti-inflammatory, anti-edematous,
osteoinductive, and pro-angiogenic properties. These
studies indicate that HA speeds up the wound healing process and promotes
regeneration by maintaining the viability of oral fibroblasts, increasing their
proliferative and migratory abilities, and enhancing the expression of genes
encoding type III collagen .Thus, the present study aims to evaluate the efficacy of bone
formation in horizontal bony defects with Intramarrow penetration clinically
and radiographically with and without Hyaluronic acid. |